The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Tuna System, Models 8909, 8929, 8930, 8934.
| Device ID | K052413 |
| 510k Number | K052413 |
| Device Name: | TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | MEDTRONIC VASCULAR 4000 LEXINGTON AVE. N Shoreview, MN 55126 -2983 |
| Contact | Julie Goode |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-09-02 |
| Decision Date | 2005-11-17 |
| Summary: | summary |